Study on the Risk Signal Mining Related to Linezolid Based on the US Food and Drug Administration Adverse Event Reporting System
Objective:To mine and analyze the adverse event(AE)signals of linezolid,so as to provide reference for clinical safety application.Methods:The AE reports on linezolid included in the FDA Adverse Event Reporting System(FAEAS)data from the second quarter of 2010 to the third quarter of 2021were collected,and the AE risk signals were explored by using the report odds ratio(ROR)method.Results:A total of 93 preferred terms(PT)with linezolid as the primary suspect(PS)drug were collected.Seven PTs were marked as"unknown"in the drug instructions,two PTs were marked as"rare"in the drug instructions,eight PTs were marked as"infrequent"in the drug instructions,and one PT(hypoglycemia)was mentioned in the drug instructions but not classified.62 PTs were not included in the package inserts,of which 10 were related to infection and infectious diseases,9 were related to blood and lymphatic system diseases,and 7 were related to various examinations.Conclusion:The AEs that occurred after the listing of linezolid are more consistent with the categories included in the instructions.During the clinical use,attention should be paid to the 17 AEs and the risk of hypoglycemia that have been marked as"unknown""rare"and"infrequent"in the instructions.A total of 63 new suspicious risk signals were discovered this time,and more attention should be paid to such signals.
Adverse drug reactionAdverse eventAdverse event reporting systemsUnited States Food and Drug AdministrationData miningSignal processingComputer assistedLinezolid
NETL
NSTL
万方数据
